Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Shot Blocker | The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED). Shot Blocker: Shot Blocker is a device that instantly alleviates the pain and anxiety of needle injections when pressed firmly against the skin at the injection site. | 0 | None | 0 | 12 | 0 | 12 | View |
| Buzzy II | The three interventional groups are currently marketed distraction devices. Arm 3 will be Buzzy® II (vibrating and ice wings) Number 51-75 (BLUE). Buzzy Bee with Ice pack: Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack. | 0 | None | 0 | 11 | 0 | 11 | View |
| Control Group | The control group is the current clinical standard of care option for pre-allergy injection application. Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW). | 0 | None | 0 | 9 | 0 | 9 | View |
| Buzzy I | The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN). Buzzy Bee without Ice pack: Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used without an ice pack. | 0 | None | 0 | 8 | 0 | 8 | View |